Warning letters, 483s, Recalls, Import Alerts, Audit observations
The DRL site was inspected by USFDA (Investigators Saleem A Akhtar & Pratik S Upadhyay)
Natco Pharma (india) Kothur facility was inspected by USFDA (Investigators Pratik S. Upadhyay and Saleem
USFDA 483 / UCB Farchim SA/ June 2023 / Deficiencies in Method Transfer, Material receipt
Qvent post discusses the Regulatory guidances and Requirements for Electronic data controls and review, Data
SCYNEXIS recalled 2 lots of Brexafemme (ibrexafungerp) tablets in U.S. due to potential cross contamination
Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
The Warning letter cite Failure of Quality unit in ensuring cGMP compliance, Inadequate control over
